MAUDE Adverse Event Report: LEICA BIOSYSTEMS POLERIS II TISSUE PROCESSOR

Device Problem Failure to Cycle (1142)

Patient Problem Tissue Damage (2104)

Event Date 09/10/2016

Event Type  Injury  

Event Description

Poleris tissue processor failed resulting in dehydrated onboarded tissue and loss of tissue viability for breast tissue biopsy.

• Brand Name: POLERIS II TISSUE PROCESSOR
• Type of Device: TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS; buffalo grove IL
• MDR Report Key: 6039627
• MDR Text Key: 57965025
• Report Number: 6039627
• Device Sequence Number: 1
• Product Code: IEO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2016
• Distributor Facility Aware Date: 09/12/2016
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR